FDA inspections are typically the starting point for the sequence of enforcement actions, since serious violations discovered at inspections will often result in Warning Letters, which in turn, if not properly responded to, can turn into seizures, injunctions, prosecutions, or recalls or consent decrees. So you can look at the number of inspections as one indicator of how aggressive FDA is being regarding enforcement. The seminar will provide an in-depth overview of the various enforcement actions, with primary focus an emphasis on Warning Letters, Seizures, Injunctions and Prosecutions. However, this seminar address as part of a high-level snapshot a multitude of enforcement actions, including 483/EIR enforcement actions, but not limited to:

• Application Actions

• Certification Withholding or Revocation

• Citation

• Civil Penalty

• Disqualification

• Demand for Destruction

• Emergency Permit Disapproved

• Injunction

• License Action (Denial, Suspension, Revocation)

• Prosecution

• Recall

• Remove from Shippers' List

• Seizure/Detention

We will address FDA enforcement stats in this space with some regularity, trying to discern patterns and trends as related to current state vs. future state. We will address the critical approach necessary to develop a quality remediation plan for inspectional observations (e.g., FDA Form 483/Warning Letter) submitted by FDA. We will examine the importance of having a detailed understanding of the observations and their impact on all quality sub-systems. Management will need to ensure a clear and scientific strategy is developed and communicated to FDA. This is critical to re-establish credibility with FDA and, hopefully, prevent an escalation to a Warning Letter or injunction (i.e., Consent Decree). There are also important technical writing and formatting rules that should be followed when writing one's response. Inadvisable response strategies and deficient remediation efforts will be discussed. Ultimately, the hard work in developing a quality remediation plan will help ensure FDA does not proceed to enforcement actions such as a Warning Letter or worse.

Why should you attend?

• Address different types of Warning Letters

• Understanding FDA's enforcement strategy and what it means to your firm

• A communication to the firm that has been reviewed within several levels of the FDA, including the district office and the Center at FDA's headquarters

• The Warning Letter generally states that the firm has made products that are adulterated, violating the Food, Drug, and Cosmetic Act and that the firm has a very limited amount of time to address the problem(s) before the FDA takes further regulatory action against the firm, the adulterated product, and responsible individuals

Lecture 3: Recap of Day 1

Day 2 – June 6th 2014

Lecture 4: Seizures

• Seizures are approved by a U.S. Federal Court judge; U.S. Marshals accompany the FDA during a seizure

• After seizure, no one may tamper with the goods except by permission of the court

• The court usually gives the owner or claimant of the seized merchandise approximately 30 days to decide a course of action

• General Guidelines for Seizures

• Types of Seizures

• Direct Reference Seizure Authority

• Approval Process for Seizure and Injunction Cases

• Responsibilities for Seizure Actions

Lecture 5: Injunctions

• Adequate Notice Preceding Injunction Actions

• Prerequisites for a TRO or Preliminary Injunction

• Refreshing Evidence - Updating Inspections

• Approval Process for Seizure and Injunction Cases

• Responsibilities for Injunction Actions

• Cover Letter to DOJ

• Complaint for Injunction

• Declarations

• Consent Decree

• Costs of Supervision

• Compliance Follow-Up

• Vacating Injunctions

Lecture 6: Prosecution

• Criminal Prosecution: In some cases, usually involving fraud, FDA and federal prosecutors will file criminal charges against an individual. If found guilty, the person is subject to fines and prison time.

• Punishment in a prosecution and sentencing guidelines and recent examples

• In furtherance of Commissioner Hamburg's call-to-action, FDA has issued special procedures and considerations for "Park" prosecution recommendations now...industry is on notice.

• Communication Between OCI and Other FDA Components

• Processing A Summary And Recommendation

• Criminal Prosecution after Section 305 Notice

• Criminal Prosecution Without Section 305 Notice

Lecture 7: Exercise and Recap of Day 2

• Exercise

• Quiz

Who Will Benefit:

• Individuals who come in contact with regulatory inspectors

• Auditors

• Compliance/Regulatory affairs professionals

• QA/QC professionals

• Senior management executives (CEO, COO, CFO, etc.)

• Manufacturing managers, supervisors & personnel

• Project Managers

• Regulatory Affairs Management

• Regulatory Affairs Specialist

• Auditors

• Compliance Officer

• Compliance Specialist

• Clinical Affairs

• Quality Assurance Management

• Marketing & Sales

• Operations/Manufacturing

• Consultants

About Speaker:

David R. Dills

Regulatory Affairs & Compliance Consultant,

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He has been involved in many FDA and other regulatory inspections as well as part of multiple FDA remediation activities involving CIA's Consent Decrees, Seizures and other enforcement actions, including responding to Warning Letters. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.

DATE, VENUE & PRICE:

Location: Boston Date: July 10th & 11th 2014 Time: 9 AM to 6 PM EDT

Venue: WILL BE ANNOUNCED SOON

Price: $1,295.00

Register now and save $200. (Early Bird)

Until May 31, Early Bird Price: $1,295.00

From June 01 to July 08, Regular Price: $1,495.00

Contact Information:

Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884

Email: support@globalcompliancepanel.com

Website: https://www.globalcompliancepanel.com

LIVE CHAT SUPPORT ALSO - http://www.globalcompliancepanel.com/chat/client.php

Email Newsletters

Want to be up-to-date with the latest news and updates from Entrepreneurship.org? To subscribe, just give us your email address below; you'll choose which e-newsletters you'd like to receive on the next screen.

Email Newsletter Sign-up Form

Enter your Email Address:Submit

Socialize With Us

Choose your favorite social media channels to keep up with the latest activity on Entrepreneurship.org.